The NIH Common Fund HMO Collaboratory working group is
seeking input on the ability of existing or newly established health care
research networks with electronic health records and linked bio-specimen
repositories to conduct large scale epidemiological or genetic studies in a cost
effective way. Advice is being sought from stakeholders within healthcare
delivery systems, the extramural research community, and other interested
groups on the current capacity of the field to leverage existing databases
linked to new or existing bio-specimen repositories. Information is being
sought regarding what questions can be addressed, what resources are currently
available for this purpose, and what additional resources need to be developed
to further capitalize on the available data to answer pressing health
questions.

Background

NIH is working to foster research collaborations across a
number of U.S. health care delivery systems. Several of these networks have
extraordinary administrative and clinical data resources to support research, including
comprehensive electronic medical records and robust disease-specific registries
for multiple key health behaviors and chronic conditions (e.g., coronary heart
disease, heart failure, diabetes, hypertension, dyslipidemia). In addition,
some of these databases are linked to bio-specimen repositories. Efforts are
underway to determine the feasibility and best ways to harmonize data collected
across multiple databases to facilitate large, multi-institution
epidemiological or genetic studies that take advantage of linked bio-specimen
repositories. It is envisioned that within such distributed networks,
participating health care organizations might combine their clinical data for
phenotypic assessment, but retain tissue samples within each health care system.
It is thought that a distributed model could permit large sample sizes more
cost effectively than standard centralized resources. Advice is sought from
stakeholders on how these resources can best be leveraged for this purpose.

Information Requested

The Common Fund HMO Collaboratory working group at the NIH
solicits input from organizations and individuals interested in epidemiological
and genetic research in healthcare delivery systems with existing data
repositories adaptable for research purposes. The NIH is committed to
fostering the development of collaborative relationships between the
bio-medical research community and healthcare delivery systems to facilitate
data sharing and use of existing large databases and bio-repositories for large
scale epidemiological and genetic research. Comments on the following issues
are sought.

1. What large-scale epidemiological or genetic studies can
be conducted utilizing an extensive, distributed research network linked to
bio-specimen repositories? Would these studies be of substantial immediate or
sustained clinical impact? Would these studies address currently unanswerable
but pressing health questions?

2. What additional efforts or resources should be
developed to enhance the value and utility of distributed clinical databases
for use in epidemiological and genetic studies, and pragmatic trials?

2A. Standard data elements typically collected in large
clinical databases include demographic variables, health services
utilization, prescription drug use, and disease diagnosis (ICD codes).
Which of these elements should be harmonized across database to facilitate the
development of distributed research networks? What additional data elements or
information would add significant scientific value and utility to an expanded
databases?

3. What additional efforts or resources should be developed
to improve the collection and use of network bio-specimen repositories?

3A. Describe the optimal model for a distributed research
network bio-specimen collection. Can current bio-repositories be expanded or
adapted for this purpose or will new primary collection sites be required?

3B. What are the advantages or disadvantages, including
cost-effectiveness, of the following:

- A large repository for each network partner

- A central repository for the entire network

- A large repository with samples from multiple
networks

3C. What are the advantages or disadvantages of using
discarded clinical bio-specimens (e.g., blood, plasma, serum, urine, placenta)
versus collecting bio-specimens obtained from re-contacting and consenting
subjects? What are the expected genotypic or phenotypic information that can
be expected from these different types of tissue? Are these samples adaptable
to tissue microarrays?

3D. Under what conditions would re-contacting subjects be
inappropriate, unethical or impossible?

3E. Describe the anticipated resource needs of a large
scale central bio-specimen repository.

General
Information

Please identify the nature of your interest in the topics
discussed. If you are a member of a particular advocacy or professional
organization, please indicate the name of the organization. Within research,
please indicate your main area of investigation.

How
to Submit a Response

All comments must be submitted electronically to the
following web address: http://commonfund.nih.gov/hmocollaboratory/rfi.aspx.
Comments will be accepted through June 1, 2011. You will receive an
electronic confirmation acknowledging receipt of your response, but will not
receive individualized feedback from the NIH Common Fund HMO Collaboratory on
any comments. Responders need not address all the issues presented in this
document and may comment on as few as one issue.

Responses to this RFI are voluntary. Any personal
identifiers (e.g., names, addresses, e-mail addresses, etc.) will be removed
when responses are compiled. Only the de-identified comments will be
used. Proprietary, classified, confidential, or sensitive information
should not be included in your response. The Government reserves the
right to use any non-proprietary technical information in any resultant
solicitation(s).

This Request for Information (RFI) is for information and
planning purposes only and should not be construed as a solicitation or as an
obligation on the part of the Federal Government, the National Institutes of
Health (NIH), and/or the NIH Common Fund HMO Research Network. The NIH does not
intend to make any awards based on responses to this RFI or to otherwise pay
for the preparation of any information submitted or for the Government's use of
such information.